Product Development / Design Control Coordinator
PRODUCT DEVELOPMENT / DESIGN CONTROL COORDINATOR
We are an International medical device company that develops, supplies and markets high quality, innovative surgical devices – from niche consumables to proprietary surgical instruments – for minimally invasive and open surgery as well as leading healthcare technology and solutions supplier of high-quality surgical instrumentation, a full line Electrosurgery portfolio.
Why work with The OR Company
At The OR Company we are dedicated to fostering growth and development and a high performance culture where employee can shine. Our values are Trust, Teamwork, Passion, Excellence, Innovation which guides are principles for mutual benefit and the ability to add value.
Not only will you benefit by being exposed to all aspects of our business but you will also have access to the following benefits:
- – Competitive salary package
- – Reward and Recognition program ‘Preciate’
- – Team lunches and celebrations
- – Bonus program
- – Casual Fridays
- – Flexible work arrangements
- – Social events (Kick off meetings, team building, Christmas party)
- – Development plans (e-University)
We currently have an opportunity for a Product Development / Design Control Coordinator to drive new and existing product launches through the completion of technical files to meet regulatory requirements and approved to be sold globally.
Based in the Cheltenham, the role will work closely with international manufacturers, international customer, regulatory bodies and quality management/ product development team to make sure that all documents is up to date in line with ISO13485 and regulatory standards.
If you are a passionate about processes, detail, providing exceptional documentation, team work and have great organisation skills then this role is for you!
Roles and Responsibilities
- – Fulfil Project Management Role along with Manager for a distinct set of clients by serving as secondary client contact for QA Manager, translating client needs into a defined scope of work, and working with QA Manager, Product Development and Design Control Manager and Management Team and effectively complete client deliverables.
- – Implement processes and procedures and conduct analyses to sustain and improve the Quality Management Systems in relation to ISO: 13485. Examples include risk planning, analysis, design controls, verification and validation, and inspection methods and procedures.
- – Work along side your Manager to develop and maintain company design history files (DHF) and Technical Files for all products and meet CE and FDA standards.
- – Conduct post-market surveillance activities and liaising with the Quality Assurance and Regulatory Affairs Manager in customer complaints handling, MDR evaluations, and CAPA assessments.
- – Responsible for effectively communicating with vendors inclusive of Contract Manufacturers and Distributors and achieving project deliverables for devices (e.g. design transfers and launch of new devices to be registered).
- – Supporting Top Management and consulting group in the development and implementation of Quality Objectives and project deliverables.
- – Use creative problem solving skills to identify, solve, and/or improve process anomalies.
- – Work with suppliers, laboratories, manufacturers, and other group members to assist with implementation and effectiveness of product/project deliverables.
- – Work with Manager and Vendors to generate Technical Files and implement document controls and transfers.
- – Maintain both soft and hard copies of all data, procedures, and test protocols/ reports for accuracy and technical application of standards (ISO: 13485).
Knowledge, Experience and Expertise:
- – Thorough understanding of Medical Device Industry.
- – Thorough understanding of ISO: 13485 and Regulatory.
- – Thorough understanding of managing projects.
- – Effective management of projects.
- – Communication and negotiation.
- – Understanding of a multi-faceted business operation.
- – In depth knowledge of markets and changing business environments.
- – Complex problem solving.
- – Effective decision making.
Key Work/ Behavioral Competencies:
- – Must demonstrate competence in the medical device quality system regulations and ISO: 13485.
- – Able to apply quality tools techniques such as: design controls, quality system auditing, inspection methods, statistical sampling plans, gauging studies, design verification and validation, and process validation.
- – Ability to apply mathematical concepts such as statistical inference and probability.
- – Ability to apply logic, creativity, and scientific thinking to a wide range of intellectual and practical problems.
- – Project management and liaise with all relevant internal and external key stakeholders.
- – Demonstrates ownership for the integrity of work.
- – Able to work independently and consider options for completing work.
- – Strong written and verbal communication skills.
- – Working knowledge of FDA regulatory premarket notification processes and labelling requirements.
- – Must be able to manage projects and work with team members to complete tasks on time and within budget.
Professional / Tertiary Qualifications:
- – Minimum 1-2 years’ experience.
- – Bachelor Degree in Biomedical Science or Electrical / Mechanical engineering
- – Experience in medical device industry and Quality Management System standards and meeting regulatory requirements.
- – Experience of building a project plans and project management desired.
- – Experience in product development and risk management.
Please email your resume and cover letter to firstname.lastname@example.org to apply.